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A Preliminary Exploratory Study of Cadonilimab Combined With Progestin for Fertility-Sparing Treatment in Early Endometrial Cancer
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Summary
This is a single-center, prospective, open-label, single-arm exploratory phase II study evaluating the efficacy and safety of cadonilimab combined with megestrol acetate as fertility-sparing treatment for patients with progestin-resistant early-stage endometrial cancer. Approximately 10 participants will be enrolled. Participants will receive cadonilimab 6 mg/kg intravenously every 3 weeks in combination with oral megestrol acetate 160 mg once daily. The primary outcomes are complete response rate (CRR) and duration of complete response (DOR). The study will also assess treatment-related adverse events, recurrence, pregnancy, and live birth outcomes.
Official title: A Study on the Safety and Efficacy of Cadonilimab Combined With Progestin in Fertility-Sparing Treatment for Endometrial Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2026-10-01
Completion Date
2033-04-01
Last Updated
2026-10-28
Healthy Volunteers
No
Conditions
Interventions
Cadonilimab
Cadonilimab 6 mg/kg will be administered by intravenous infusion every 3 weeks in combination with oral megestrol acetate. Treatment response will be assessed approximately every 12 weeks, with a maximum efficacy observation period of 6 months.
Megestrol Acetate (MA)
Megestrol acetate 160 mg will be administered orally once daily in combination with cadonilimab. Treatment response will be assessed approximately every 12 weeks, with a maximum efficacy observation period of 6 months.
Levonorgestrel-releasing intrauterine system
Participants who achieve two consecutive pathological complete responses will discontinue cadonilimab and megestrol acetate and receive a levonorgestrel-releasing intrauterine system for maintenance management and subsequent follow-up.